Clinical and Instrumental Evaluation of the Safety and Bio-revitalizing Effect on the Face of the Medical Device Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen

What this Trial Is About

This research aims to evaluate the safety and effectiveness of a volumizing filler made from hyaluronic acid and recombinant collagen in adults with facial laxity, wrinkles, scars, and skin laxity. The study is sponsored by Taumedika s.r.l. and involves 40 patients who will receive treatment to improve facial appearance and skin condition. Participants will receive microinjections of the Karisma device in the cheekbone area, lips, and marionette lines during the first visit. The treatment effects will be assessed at 4 weeks and 16 weeks after injection, with non-invasive measurements to evaluate changes in the skin's tissue structure and wrinkle appearance. The study includes three visits: one for treatment and health assessment, a second at 4 weeks for initial results, and a final visit at 16 weeks for outcome validation. During the study, participants will undergo health checks and assessments of wrinkle and scar changes, with safety monitored through adverse event analysis. The main outcomes measured are safety (absence of adverse events) and efficacy (improvement in wrinkles and scars) at 16 weeks post-treatment. Secondary outcomes include the duration of treatment effects. The total study duration for each participant is 16 weeks, with evaluations during each visit to monitor progress and safety.

Pre-marketing Trial to Assess Safety and Efficacy of 'Volumizing Filler Based on Hyaluronic Acid and Recombinant Collagen'